Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 Jun - 18 Jul 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Limited details on inhalation exposure given, no data on MMAD given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
as adopted 12 May 1981
Deviations:
yes
Remarks:
limited data on inhalation exposure given, no data MMAD given
GLP compliance:
yes
Test type:
traditional method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Hoechst Celanese Corporation, batch 55312
- Expiration date of the lot/batch: 30 Dec 1991
- Purity test date: >99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature, in the original container, protected from light

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was used as supplied.

FORM AS APPLIED IN THE TEST (if different from that of starting material): For the low and mid dose group the test material was administered following vaporization. For the high dose group the test material was nebulized followed by filtration.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd, CH-4414 Fuellinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 8 weeks; females 10 weeks
- Weight at study initiation: males: 180 - 192 g; females: 186 - 200 g
- Housing: in groups of five in Makrolon cages type 4 with softwood bedding
- Diet: pelleted standard Kliba 343 maintance diet, ad libitum
- Water: community tap water from Geneva, ad libitum
- Acclimation period: 4 to 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 15
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod: 12/12

IN-LIFE DATES: From: 24 Jun 1991 To:18 Jul 1991

Administration / exposure

Route of administration:
other: Inhalation: For the low and mid dose group the test material was administered following vaporization. For the high dose group the test material was nebulized followed by filtration.
Type of inhalation exposure:
nose only
Vehicle:
air
Remark on MMAD/GSD:
no data provided
Details on inhalation exposure:
no data provided
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0.089, 0.546 and 4.77 mg/L air (analytical concentration)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality were observed daily. Body weights were recorded prior to exposure and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights
Statistics:
A statistical analysis was not necessary/possible as no mortalities were noted.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 4.77 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortalities occurred during the study.
Clinical signs:
Restlessness was noted in all animals of the high dose group (4.77 mg/L) during exposure. This sign as well as hunched posture, ruffled fur and tachypnea (males only) were observed on test day 1 after exposure. Ruffled fur lasted until test day 2 in all high dose animals.
Body weight:
No treatment-related effects on body weights were noted.
Gross pathology:
Isolated dark red or reddish foci were noted on one or several lung lobes of 2 males and 2 females, 4 males and 2 females of the low and mid dose group, respectively. No necropsy findings were noted in animals of the high dose group.

Any other information on results incl. tables

Table 1. Table for acute toxicity following inhalation

Target concentration
[mg/L air]

Toxicological results*

Duration of clinical signs

Time of death

Mortality (%)

Males

0.089

0/0/5

---

---

0

0.546

0/0/5

---

---

0

4.77

0/5/5

Day 1-2

---

0

Females

0.089

0/0/5

---

---

0

0.546

0/0/5

---

---

0

4.77

0/5/5

Day 1-2

---

0

LC50 > 4.77 mg/L air

* first number = number of dead animals   

 second number = number of animals with clinical signs

 third number = number of animals used 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
2-chlorophenol is classified as Acute Tox. 4, H332 according to Annex VI of Regulation (EC) No 1272/2008. Although the available data on acute toxicity following inhalation do not meet the classification criteria according to Regulation (EC) No 1272/2008, the registrant follows the harmonised classification.
Conclusions:
CLP: Acute toxicity, Cat. 4, H332